Overview
- 9 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
9 Dec 2021
21 CFR 211.160(b)(4)
Written calibration procedures
Cited by Santiago Gallardo Johnson, Claudia M Perez-Kasmarski
9 Dec 2021
21 CFR 211.165(a)
Testing and release for distribution
Cited by Santiago Gallardo Johnson, Claudia M Perez-Kasmarski
9 Dec 2021
21 CFR 211.165(d)
Acceptance criteria for sampling & testing
Cited by Santiago Gallardo Johnson, Claudia M Perez-Kasmarski
9 Dec 2021
21 CFR 211.180(e)(1)
Review of representative number of batches
Cited by Santiago Gallardo Johnson, Claudia M Perez-Kasmarski
9 Dec 2021
21 CFR 211.184(d)
Labeling: documentation of exam and review
Cited by Santiago Gallardo Johnson, Claudia M Perez-Kasmarski
Inspected site
GCGenlabs CorporationChino, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(1) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 9 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere